Clip device for vascular catheter

ABSTRACT

A vascular dilatation catheter including an elongated catheter shaft having a distal and a proximal end and a first lumen extending therethrough fluid connection with a distally located balloon and a second lumen capable of receiving a guidewire is provided with a clip device attached about a proximal portion of the catheter shaft and adapted to releasibly secure the catheter shaft in a coiled configuration between uses.

This application is a division of application Ser. No. 08/885,533, nowU.S. Pat. No. 5,830,183 filed Jun. 30, 1997, entitled “CLIP DEVICE FORVASCULAR CATHETER”.

BACKGROUND OF THE INVENTION

I. Field of the Invention

The present invention relates generally to vascular catheter systems andparticularly to catheter systems that employ inflatable balloon devicesto accomplish mechanical dilitation of vascular stenoses, moreparticularly those occurring in coronary arteries. The invention itselfinvolves a clip device for convenient temporary retention of a cathetershaft in coiled form during interim periods when one of possibly severalcatheters being used in a procedure is temporarily removed from aguidewire between uses during the procedure. The clip device ispreferably a single piece and includes a hub.

II. Related Art

Percutaneous dilitation of coronary stenoses by balloon dilitationcatheter devices has evolved into an acceptance or a standard approachto alleviating many types of arterial blockages, especially partialcoronary blockages, as it has, over the years, been demonstrated to bean effective, relatively low-risk procedure. During such procedures,often several different types of dilitation catheters are employedsequentially utilizing the same guidewire and, in some cases, thecatheters may be alternately used several times, being inserted throughthe vascular system over an already indwelling guidewire. The cathetershafts are typically quite long, i.e., from about 70 cm. to about 150cm. Once removed from the guidewire, the entire catheter may be setaside and kept within the sterile field for reuse. The length of thecatheter shaft makes this quite inconvenient and awkward. No convenientdevice has been available to retain the catheter shaft in the coiledconfiguration until the next use. Thus, there remains a need for asystem, particularly one integral with the catheter device itself forthe temporary storage of the catheter shaft between uses which is easilyoperable and does not in any way interfere with the designed use of thecatheter system.

Accordingly, it is a primary object of the present invention to providean retention system for retaining a vascular catheter shaft in arelatively compact coiled configuration between the uses thereof.

Another object of the present invention is to provide a retention systemfor a coiled catheter shaft which is an integral part of and does nototherwise interfere with the normal operation of the catheter.

Yet another object of the present invention is to provide an integralhub/clip retention system for a coiled catheter shaft that isinexpensive and easy to operate.

Other objects and advantages of the invention will become apparent tothose skilled in the art upon familiarization with the specifications,drawings and claims contained in this application.

SUMMARY OF THE INVENTION

According to the present invention, there is provided a convenient, easyto operate combination hub and clip device for releasibly securing anassociated catheter shaft in a coiled configuration between deploymentsthereof. According to the invention, a hollow clip device is mounted atthe proximal end of the catheter shaft and is designed to connect thecatheter shaft to any associated external devices such as combinedguidewire and inflation fluid input manifolds, or the like. The clip isdesigned with a hollow interior which allows the manifold or otherconnected device to access the various catheter lumens as desired. Theclip device may incorporate a hub which, in turn, may be provided withan integral leuer proximal fitting to engage the manifold or other suchconnectable device. Of course, any other desired fitting may be moldedto the body of the clip, without limitation.

The clip device particularly includes a system for releasibly securingthe catheter shaft in a coiled configuration of one or more loops. Thisincludes the provision of an external recess for accommodating aplurality of loops of the catheter shaft in the coiled configuration anda hinged clasp lid for providing a reclosable snap-fit latch over thecoiled shaft to retain the coiled catheter shaft in the recess. Thehinge attaching the clasp lid to the body of the clip is a flexible butpreferably integral part of the clip device.

The clip including the hinged clasp lid is preferably molded as asingle-piece system with the hinge being a “living” hinge capable ofeasy flexure and capable of being flexed a plurality of times duringwhich the clasp lid is repeatedly opened and closed. The clip and clasplid may be molded from a single polymer material in a one-shot injectionmolding operation. It is further contemplated, however, that a pluralityof materials could be used, including a material for the hinge and clipthat is somewhat softer and more pliable than that utilized for the mainbody of an associated hub. It should be recognized further that anyappropriate moldable plastic material can be used for the device that iscapable of being formed with internal passages and retaining its shapeduring use. These include many acrylic and polycarbonate materials,styrenes, ABS and other materials. The hinge and clip may be made of thesame or rather softer polyester materials such as polyesters includingHytrel (Dupont), nylons, and other polymer materials such aspolyethylenes, polypropylenes and other compatible materials. If twodifferent materials are used, the device can be made by a two-shotprocess whereby both materials are injected at different gates into themold cavity. Other processes are also feasible, such as insert molding.

An aspect of the integral hub and clip system of the invention is theharmonious manner in which the device can be incorporated in thecatheter system without affecting the catheter itself or the devices tobe attached to the proximal end of the catheter. In addition, itutilizes an easily operable snap lid latch and the overall configurationis one which does not interfere with the normal use and operation of thecatheter system or get in the way during its use in a procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, wherein like parts are represented by like referencenumerals throughout the same:

FIG. 1 depicts a rapid exchange balloon dilitation catheter includingthe clip device of the invention;

FIG. 2 depicts an over the wire balloon dilitation catheter includingthe clip device of the invention;

FIG. 3 is an enlarged view of the clip of FIG. 1 with the clasp lidlatched in the closed position and illustrating several loops of a coilof the catheter shaft shown broken and secured to the hub by the closedclasp lid;

FIG. 4 is a bottom view of the hub of FIG. 3 without the illustratedcoils;

FIGS. 5 and 6 illustrate views of the hub device of FIGS. 3 and 4 withthe clasp lid open; and

FIGS. 7 and 8 are enlarged perspective views of a hub device with theclasp lid in the open and closed positions, respectively, showing apossible latch.

DETAILED DESCRIPTION

In the detailed description, the combination hub clip is illustratedwith regard to one or more particular embodiments. These embodiments areintended merely to illustrate the principles of the invention and not tolimit the outward appearance or possible uses of the system. It iscontemplated, for example, that the hub may be mounted on differentcatheter devices.

FIG. 1 illustrates a rapid exchange balloon dilitation catheter deviceof a class suitable for and, in fact, incorporating the hub clip systemof the invention. The catheter device is generally represented by thenumber 20.

The connecting hub is depicted at 22, including a body element 24 and aclasp lid 26 suitably and integrally hinged at 28 to the body element24. The proximal end 30 of the hub device 22 may be connected removablyto any suitable accessory such as a manifold in the form of an integralY-adaptor (FIG. 2) as a leuer fitting 62, or the like. The distal end 32is adapted to receive the catheter shaft 34 utilizing a reinforcing orstrengthening transition segment 35. A shive or guidewire port for therapid exchange catheter device is shown at 37. A dilitation balloon orexpander device 38 incorporated as part of the catheter 20 in awell-known manner. Radiopaque markers useful for assisting placement andpositioning of the expander 38 are depicted by 40 and 41.

FIG. 2 illustrates the over the wire dilitation catheter device of FIG.1 incorporating the clip system of the invention in which the proximalend of the hub device includes an integral Y-adaptor shown generally as42. The adaptor 42 connects and accesses external devices using tubularports, examples of which are depicted at 44 and 45 with connectingmembers 46 and 47, respectively. Separation between access via Y-adaptor42 is maintained internally in a well-known manner.

The illustrated catheter shaft 34 of FIG. 2 is typically a two-lumenshaft that includes a guidewire lumen through which a guidewire, the tipof which appears at 36, can be threaded using one of the accesses 44 and45. Of course, any rethreading of a catheter for a second or third useinvolves threading the catheter over a guidewire already in place in thevascular system. The other access 44 or 45 is connected with a pressurelumen which serves to conduct fluid reversibly from a source to inflatethe dilitation balloon or expander device 38.

The clip device itself is depicted in greater detail in FIGS. 3-8. Ascan be seen from the figures, the body 24 of the hub device 22 isprovided with a shallow recess at 50 (FIG. 5) to accommodate a portionof the clasp lid 26 thereby maintaining relatively smooth outerconfiguration for the hub when the clasp lid is closed. The hub deviceis further provided with a longitudinal open-ended recess 52 which isdesigned to accommodate and capture one or more turns or coils of thecatheter shaft 34 as shown in FIG. 3. A snap-fitting clasp or catch lipis illustrated on the lid at 54 which cooperates with a catch 56 on theclip body to provide a finger-operable snap-fit closure. These featuresare shown exaggerated in FIGS. 7 and 8 for the purposes of illustrationonly.

The configuration and operation of snap latches of the class is quitewell known and it will be appreciated that the force required to openand close such a latch can be varied with respect to the construction ofthe device such that the desired closure tension is achieved. It will beappreciated that the hinge member 28 is preferably rather thin and ableto accommodate a number of repeated flexings while functioning so thatit remains intact in a manner such that the clasp lid 26 may be operateda number of times to capture and release turns of the catheter shaft asnecessary during the use of the catheter in a procedure. It will furtherbe noted that the system can readily be operated occupying but one handof the user.

The device itself is preferably molded in a one or two-shot moldingoperation with the hinge and lid portion being integrally formed. Theentire assembly may be constructed of a single molded polymeric materialin a oneshot process or may utilize diverse materials for the main bodyof the hub and the hinge and clip. In this manner, the system may beformed using a multi-step process with a plurality of materials possiblyin a two-shot process in which both materials are injected at separateaccesses into the mold cavity. Of course, other established processes offabricating such devices, such as insert molding, may be employed bythose skilled in the art as well.

It will be appreciated that any moldable polymer material susceptible offorming the hub with the required internal passages and external recess,together with the integral living hinge and clasp lid and which iscompatible with the remainder of the catheter device may be utilized.The list of materials includes, but clearly is not limited to, acrylicmaterials, polyester materials, polycarbonate materials, styrene, ABSand many others. A slightly softer material such as Hytrel polyester andvarious polyalkene materials such as polyethylene and polypropylene maybe utilized for the hinge and clip portion, assuming that a hardermaterial is used for the associated hub itself, if desired.

The clip device of the present invention may form the proximal end of acatheter. Alternatively, it may be attached to a catheter shaft at apoint distal of the proximal end of the catheter, such as within 10 cm.of the proximal end of the catheter in which case the catheter shaftwould pass through and be bonded to an inner lumen of the clip.

This invention has been described herein in considerable detail in orderto comply with the Patent Statutes and to provide those skilled in theart with the information needed to apply the novel principles and toconstruct and use such specialized components as are required. However,it is to be understood that the invention can be carried out byspecifically different equipment and devices, and that variousmodifications, both as to the equipment details and operatingprocedures, can be accomplished without departing from the scope of theinvention itself.

What is claimed is:
 1. An integral hub and clip device for a vascularcatheter comprising: (a) a hub portion including a hub body and a firstchannel surrounded by and permanently closed by the hub body said firstchannel configured to couple to a proximal end of a catheter shaft andthe hub portion including at least one device port in fluidcommunication with the first channel and the device port adapted tofluidly coupled to a lumen of the catheter shaft; and (b) a hinged clipportion to releasably secure at least one loop of a catheter shaftportion to said hub portion in a coiled disposition, the clip portionbeing integral with said hub portion and forming a unitary structurewith said hub portion and the clip portion including a clip lid and ahinge movably connecting the clip lid to the hub portion to move theclip lid between an opened position and a closed position andcooperating clasp members on the clip lid and the hub portion toreleasably connect the clip lid to the hub portion to form a secondchannel between the hub portion and the clip lid in the closed positionto receive the at least one loop of the catheter shaft portion.
 2. Thedevice of claim 1 further comprising an external recess formed with saidhub body for accommodating said at least one loop of said catheter shaftportion in the coiled disposition which cooperates with said clip lid toreleasable secure said coiled catheter shaft portion in said recess. 3.The device of claim 2 wherein said external recess accommodates aplurality of loops of catheter shaft portions in a coiled configuration.4. The device of claim 1 wherein said hub portion and the clip portionare molded from a single polymer material.
 5. The device of claim 1wherein said hub portion and said clip portion are molded from aplurality of different polymer materials.
 6. The device of claim 1wherein said hub portion and said clip portion are made of a materialselected from the group consisting of polyesters and polycarbonates. 7.The device of claim 1 wherein said clip portion is made from a softermaterial than said hub portion.
 8. An integral hub and clip device for avascular catheter comprising: a hub portion including a hub body and ahub channel surrounded by and permanently closed by the hub body and thehub portion including at least one device port in fluid communicationwith the hub channel and including a connection fitting to connect adevice to the device port in fluid communication with the hub channel;and a clip portion formed integral with the hub portion and having aclip lid hingedly coupled to the hub portion to operate between anopened portion and a closed clipped position to secure a portion of acatheter shaft in the closed clipped position.
 9. The device of claim 8wherein the connection fitting is a luer connection.
 10. The device ofclaim 8 wherein the hub portion includes a plurality of device ports.11. The device of claim 8 including a “Y” adaptor coupled to theconnection fitting of the hub portion.
 12. The device of claim 8including cooperating clasp members on the clip lid and hub portion. 13.The device of claim 8 including a manifold connected to the connectionfitting of the hub portion.
 14. An integral hub and clip device for avascular catheter comprising: a hub portion including a hub body and afirst channel surrounded by and permanently closed by the hub body, thefirst channel configured to couple to a catheter shaft and the hubportion including at least one device port in fluid communication withthe first channel and the device port adapted to fluidly couple to alumen of the catheter shaft; and a clip portion being integral with saidhub portion and forming a unitary structure with said hub portion andincluding a clip lid, and a hinge movably connecting the clip lid to thehub portion to move the clip lid between an opened position and a closedposition to form a second channel between the hub portion and the cliplid in the closed position to secure at least one loop of a cathetershaft portion.
 15. The device of claim 14 wherein the device portincludes a connection fitting.
 16. The device of claim 15 wherein theconnection fitting is a leur connection.
 17. The device of claim 15including a Y-adaptor coupled to the connection fitting of the deviceport.
 18. The device of claim 15 including a manifold coupled to theconnection fitting of the device port.
 19. The device of claim 14wherein the hub portion includes at least two device ports.